Pharmacy Services

Unapproved Prescription Ear Drops For Pain and Inflammation - FDA Requiring Manufacturing to Cease

July 1, 2015

FDA is taking enforcement action against manufacturers of certain unapproved prescription ear drops labeled for treating ear infection, inflammation, and pain as part of its Unapproved Drugs Initiative. These products are frequently used in children and their safety and efficacy have not been evaluated by FDA. The product labels for these agents do not clearly state they are unapproved drugs, so physicians and pharmacists may be unaware of the product’s approval status. Because the safety, efficacy, and quality of these products have not been evaluated by FDA, patients using these products are at increased risk of complications. Sixteen unapproved prescription ear drops containing the following active ingredients are included in FDAs enforcement action:

  • Benzocaine
  • Benzocaine and antipyrine
  • Benzocaine, antipyrine, and zinc acetate
  • Benzocaine, chloroxylenol, and hydrocortisone
  • Chloroxylenol and pramoxine
  • Chloroxylenol, pramoxine, and hydrocortisone

Companies are to stop manufacturing and shipping these unapproved products immediately. Instruct patients who may be using unapproved prescription ear drops to contact their providers for an alternative. Several FDA approved prescription products for treating infection, inflammation, and pain are available.

Additional information is available at the following links:

Updated
July 1, 2015; University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.